WASHINGTON - FDA last week proposed a rule intended to ensure that neither women nor men are excluded from clinical studies of drugs and biologics to treat life-threatening diseases simply because they are able to procreate or for fear of potential fetal exposure.

The proposed rule would allow FDA to issue a clinical hold on any proposed or ongoing clinical trial for a life-threatening disease "if men or women with reproductive potential who have the disease being studied are excluded from eligibility in any phase of clinical investigation because of a risk or potential risk of reproductive toxicity (i.e., toxicity to reproductive organs) or developmental toxicity (i.e., toxicity to potential offspring) from use of the investigational drug."